Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

DQA 2016-08-18

Medke Oximetry Finger Sensor

Applicant Shenzhen Medke Technology Co., Ltd.

K-Number K152390

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IYX 2016-08-18

Sentinella 102, Sentinella 102 Horus

Applicant General Equipment For Medical Imaging (Oncovision-

K-Number K162052

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DQA 2016-08-17

Wrist Pulse Oximeter

Applicant Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.

K-Number K152089

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DJR 2016-08-17

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)

Applicant W.H.P.M., Inc.

K-Number K160793

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LLZ 2016-08-17

WebPAX

Applicant Heart Imaging Technologies, LLC

K-Number K152949

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LHN 2016-08-17

Sumitomo Proton Therapy System

Applicant Sumitomo Heavy Industries, Ltd.

K-Number K160612

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NUC 2016-08-17

Just Like Me Personal Lubricant

Applicant Wtfn-Dba Classic Erotica/Holiday Products

K-Number K161385

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JAK 2016-08-17

SUPRIA w/guideShot Option

Applicant Hitachi Medical Systems America, Inc.

K-Number K161748

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ITX 2016-08-17

UST-5550-R; UST-5536-R; L43K

Applicant Hitachi Aloka Medical America, Inc.

K-Number K152126

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FAJ 2016-08-17

Ambu USR, Ambu M

Applicant Ambu A/S

K-Number K160766

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HRS 2016-08-17

Alians Elbow Locking Plating System

Applicant Newclip Technics

K-Number K152289

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KXK 2016-08-17

SPEC Model M23

Applicant Source Production and Equipment Co., Inc.

K-Number K161396

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